FDA’s plan to ban hair relaxer chemical called too little, too late

In April, a dozen years after a federal agency classified formaldehyde a human carcinogen, the Food and Drug Administration is tentatively scheduled to unveil a proposal to consider banning the chemical in hair-straightening products.

The move comes at a time of rising alarm among researchers over the health effects of hair straighteners, products widely used by and heavily marketed to Black women. But advocates and scientists say the proposed regulation would do far too little, in addition to being far too late.

"The fact that formaldehyde is still allowed in hair care products is mind-blowing to me," said Linda Birnbaum, a former director of the National Institute of Environmental Health Sciences and the National Toxicology Program. "I don't know what we're waiting for."

Asked why it's taking so long to get the issue on the FDA's agenda, Namandjé Bumpus, the regulatory agency's chief scientist, told KFF Health News: "I think primarily the science has progressed."

"Also," she added, "the agency is always balancing multiple priorities. It is a priority for us now."

The FDA's glacial response to concerns about formaldehyde and other hazardous chemicals in hair straighteners partly reflects the agency's limited powers when it comes to cosmetics and personal-care products, according to Lynn Goldman, a former assistant administrator for toxic substances at the Environmental Protection Agency. Under the law, she said, the FDA must consider all chemical ingredients "innocent until proven guilty."

Critics say it also points to broader problems. "It's a clear example of failure in public health protection," said David Andrews, a senior scientist at the Environmental Working Group, which first petitioned the agency to ban formaldehyde in hair straighteners in 2011 and sued over the issue in 2016. "The public is still waiting for this response."

Mounting evidence linking hair straighteners to hormone-driven cancers prompted Reps. Ayanna Pressley (D-Mass.) and Shontel Brown (D-Ohio) last year to urge the regulatory agency to investigate straighteners and relaxers.

The FDA responded by proposing to do what many scientists say the agency should have done years ago — initiate a plan to eventually outlaw chemical straighteners that contain or emit formaldehyde.

Such a ban would be a crucial public health step but doesn't go nearly far enough, scientists who study the issue said. The elevated risk of breast, ovarian, and uterine cancers that epidemiological studies have recently associated with hair straighteners is likely due to ingredients other than formaldehyde, they said.

Formaldehyde has been linked to an increased risk of upper respiratory tract cancer and myeloid leukemia, Bumpus said in a video announcement of the proposed ban on X, formerly known as Twitter. But Kimberly Bertrand, an associate professor at the Boston University Chobanian & Avedisian School of Medicine, and other scientists said they were unaware of any studies linking formaldehyde to the hormone-driven, or reproductive, cancers that prompted recent calls for the FDA to act.

"It's hard for me to imagine that removing formaldehyde will have an impact on the incidence of these reproductive cancers," said Bertrand, an epidemiologist and lead author on a study published in December, the second linking hair relaxers to an increased risk of uterine cancer.

Hair products targeted to African Americans contain a host of hazardous chemicals, said Tamarra James-Todd, an associate professor of epidemiology at the Harvard T.H. Chan School of Public Health who has studied the issue for 20 years.

Studies have shown that straightener ingredients include phthalates, parabens, and other endocrine-disrupting compounds that mimic the body's hormones and have been linked to cancers as well as early puberty, fibroids, diabetes, and gestational high blood pressure, which is a key contributor to Black women's outsize risk of maternal mortality, James-Todd said.

"We have to do a better job regulating ingredients that people are exposed to, particularly some of our most vulnerable in this country," she said. "I mean, children are being exposed to these."

The first study linking hair relaxers to uterine cancer, published in 2022, found that frequent use of chemical straighteners more than doubled a woman's risk. It followed studies showing women who frequently used hair relaxers doubled their ovarian cancer risk and had a 31% higher risk of breast cancer.

Bumpus praised the studies as "scientifically sound" and said she would leave to epidemiologists and others questions about whether straightener ingredients besides formaldehyde might be contributing to an elevated risk of hormone-driven cancers.

She could not offer a timeline for a formaldehyde ban, except to say the agency was scheduled to initiate proceedings in April. The schedule could change, she said, and she did not know how long the process of finalizing a rule would take.

Brazilian Blowouts and similar hair-smoothing treatments sometimes use formaldehyde as a glue to hold the hair straight for months. Stylists usually seal the product into the hair with a flat iron. Heat converts liquid formaldehyde into a gas that creates fumes that can sicken salon workers and patrons.

In addition to cosmetics, formaldehyde is found in embalming fluid, medicines, fabric softeners, dishwashing liquid, paints, plywood, and particleboard. It irritates the throat, nose, eyes, and skin.

If there are opponents to a ban on formaldehyde in hair straighteners, they have not raised their voices. Even the Personal Care Products Council, which represents hair straightener manufacturers, supports a formaldehyde ban, spokesperson Stefanie Harrington said in an email. More than 10 years ago, she noted, a panel of industry-paid experts deemed hair products with formaldehyde unsafe when heated.

California and Maryland will ban formaldehyde from all personal-care products starting next year. And manufacturers already have curtailed their use of formaldehyde in hair care products. Reports to the California Department of Public Health's Safe Cosmetics Program show a tenfold drop in products containing formaldehyde from 2009 to 2022.

John Bailey, a former director of the FDA's Office of Cosmetics and Colors, said the federal agency often waits for the industry to voluntarily remove hazardous ingredients.

Cheryl Morrow co-founded The Relaxer Advocates late last year to lobby on behalf of California Curl, a business she inherited from her father, a barber who started the company, and other Black hair care companies and salons. "Ban it," she said of formaldehyde, "but please don't mix it up culturally with what Black people are doing."

She insisted the relaxers African Americans use contain no formaldehyde or other carcinogens and are safe.

A 2018 study found that hair products used primarily by Black women and children contained a host of hazardous ingredients. Investigators tested 18 products, from hot-oil treatments to anti-frizz polishes, conditioners, and relaxers. In each of the products they found at least four and as many as 30 endocrine-disrupting chemicals.

Racist beauty standards have long compelled girls and women with kinky hair to straighten it. Between 84% and 95% of Black women in the U.S. have reported using relaxers, studies show.

Black women's often frequent and lifelong application of chemical relaxers to their hair and scalp might explain why hormone-related cancers kill more Black women than white women per capita, Bertrand and other epidemiologists say. Relaxers can be so habit-forming that users call them "creamy crack."

As a public health educator, Astrid Williams, director of programs and initiatives at the California Black Health Network, has known the health risks associated with hair relaxers for years. Nonetheless, she used them from age 13 until two years ago, when she was 45.

"I felt I had to show up in a certain way," she said.

A formaldehyde ban won't make creamy crack safe, she said. "It's not even a band-aid. The solution is to address all chemicals that pose risk."

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.